Percutaneously-deliverable dual-frame valve

ABSTRACT

A prosthetic valve comprises a first frame, defining an arrangement of cells; a second frame, a first protrusion, and a second protrusion. In an expanded state of the valve, the first frame is generally cylindrical and has an expanded width, and the valve defines a lumen having a first end and a second end. In a compressed state of the valve, the first and second frames are both generally cylindrical, and the first frame has a compressed width that is smaller than the expanded width. In the expanded state, the valve provides directional fluid flow through the lumen. The valve defines first and second coupling points, and an axis therebetween, the axis lying on a transverse cross-section of the first frame. The first and second coupling points couple the second frame to the first frame by protruding into respective first and second slots defined by the first frame.

CROSS-REFERENCES TO RELATED APPLICATIONS

The present application is a Continuation of U.S. Ser. No. 15/354,504 toHaCohen et al., entitled “Percutaneously-deliverable mechanical valve,”which published as US 2017/0065407, which is a Continuation of U.S. Ser.No. 14/442,541 to HaCohen et al., entitled “Percutaneously-deliverablemechanical valve,” which published as US 2016/0213473 (now U.S. Pat. No.9,498,332); which is the US National Phase of PCT IL2013/050937 toHaCohen et al, entitled “Percutaneously-deliverable mechanical valve,”which published as WO 2014/076696; which is a Continuation of U.S.patent application Ser. No. 13/675,119 to HaCohen et al., entitled“Percutaneously-deliverable mechanical valve,” filed on Nov. 13, 2012(now U.S. Pat. No. 8,628,571), which is incorporated herein byreference.

FIELD OF THE INVENTION

Some applications of the present invention relate in general to valvereplacement. More specifically, some applications of the presentinvention relate to prosthetic valves for replacement of a cardiacvalve.

BACKGROUND

Ischemic heart disease causes regurgitation of a heart valve by thecombination of ischemic dysfunction of the papillary muscles, and thedilatation of the ventricle that is present in ischemic heart disease,with the subsequent displacement of the papillary muscles and thedilatation of the valve annulus.

Dilation of the annulus of the valve prevents the valve leaflets fromfully coapting when the valve is closed. Regurgitation of blood from theventricle into the atrium results in increased total stroke volume anddecreased cardiac output, and ultimate weakening of the ventriclesecondary to a volume overload and a pressure overload of the atrium.

SUMMARY OF THE INVENTION

A percutaneously-deliverable (e.g., transluminally-deliverable)mechanical prosthetic valve, comprising a tubular element and a valvemember is described. Typically, the tubular element and valve member arerestrained in respective compressed configurations for delivery, andautomatically expand into respective expanded configurations whenreleased at the native valve.

There is therefore provided, in accordance with an application of thepresent invention, apparatus for regulating blood flow of a subject, theapparatus including a prosthetic valve, the prosthetic valve:

including:

-   -   a tubular element, shaped to define a lumen therethrough, and    -   a valve member, configured to be coupled to the tubular element        and to be disposed within the lumen, and having:    -   a compressed configuration in which the lumen has a compressed        width, the valve member is generally cylindrical, and the        prosthetic valve is configured to be percutaneously delivered        into the subject, and    -   an expanded configuration in which:        -   the lumen has an expanded width that is greater than the            compressed width, and        -   the valve member is generally disc-shaped, is coupled to the            tubular element, and is disposed within the lumen.

In an application, the prosthetic valve is configured to function as acheck valve when in the expanded configuration thereof, and not when inthe compressed configuration thereof.

In an application, in the compressed configuration, the valve member iscoupled to the tubular element.

In an application, in the compressed configuration, the valve member isdisposed within the lumen.

In an application:

the lumen has a first end and a second end, and

the valve member, when the valve is in the expanded configurationthereof:

-   -   has an open state, in which the first and second ends of the        lumen are in fluid communication with each other,    -   has a closed state, in which the first and second ends of the        lumen are generally not in fluid communication with each other,        and    -   is movable between the open and closed states.

In an application, in the expanded configuration, the valve member isconfigured to move between the open and closed states in response tochanges in relative pressure between the first and second ends of thelumen.

In an application, in the expanded configuration, the valve member, inat least the closed state thereof, has a diameter that is no more than20 percent smaller than the expanded width of the lumen.

In an application, the valve member has a compressed diameter in thecompressed configuration of the prosthetic valve, and an expandeddiameter in the in the expanded configuration of the prosthetic valve,and the expanded diameter is at least twice as great as the compresseddiameter.

In an application, in the expanded configuration, the prosthetic valveis configured to act as a check valve.

In an application, in the expanded configuration, the valve member isconfigured to move toward the open state when pressure at the first endof the lumen is greater than pressure at the second end of the lumen,and to move toward the closed state when pressure at the second end ofthe lumen is greater than pressure at the first end of the lumen.

In an application, the valve member is coupled to the tubular element atat least two coupling points, the coupling points defining an axistherebetween.

In an application, the valve member is configured to move between theopen and closed states thereof, by rotating around the axis between thecoupling points.

In an application, the valve member is configured to move between theopen and closed states thereof, by deflecting around the axis betweenthe coupling points.

In an application, the apparatus further includes a coupling rod,coupled to the coupling points, and coupled to the valve member alongthe axis between the coupling points, and the valve member is configuredto move between the open and closed states thereof, by bending aroundthe coupling rod.

In an application, the prosthetic valve includes a coupling element thatincludes at least one strut, the strut being coupled to the tubularelement, and to the valve member at a coupling point that is generallymidway across a diameter of the valve member, and the valve member isconfigured to move between the open and closed states by deflecting fromthe coupling point.

In an application, the valve member is configured to move between theopen and closed states by collapsing and expanding.

In an application, the valve member is configured to move between theopen and closed states thereof without changing a shape thereof.

In an application, the prosthetic valve is configured such that, whenthe valve member moves toward the open state, at least part of the valvemember moves toward the first end of the lumen and at least part of thevalve member moves toward the second end of the lumen.

In an application, the valve member is configured to move between theopen and closed states thereof by changing a shape thereof.

In an application, the valve member is configured to be biased towardbeing in the closed state thereof.

In an application, in the compressed configuration, the prosthetic valvehas a greatest transverse diameter of less than 12 mm.

In an application, in the compressed configuration, the prosthetic valvehas a greatest transverse diameter of less than 9 mm.

In an application, in the compressed configuration, the prosthetic valvehas a greatest transverse diameter of less than 6 mm.

In an application, the prosthetic valve is intracorporeally expandablefrom the compressed configuration to the expanded configuration.

In an application, the prosthetic valve is configured to bepercutaneously delivered in the constrained configuration thereof, bybeing restrained in the compressed configuration during the percutaneousdelivery, and the prosthetic valve is configured to automatically expandtoward the expanded configuration thereof when no longer restrained.

The present invention will be more fully understood from the followingdetailed description of applications thereof, taken together with thedrawings, in which:

BRIEF DESCRIPTION OF THE DRAWINGS

FIGS. 1A-D are schematic illustrations of a prosthetic valve, comprisinga tubular element and a valve member, in accordance with someapplications of the invention;

FIGS. 2A-B are schematic illustrations of the valve member, inaccordance with respective applications of the invention;

FIGS. 3A-B are schematic illustrations of a prosthetic valve in open andclosed states thereof, in accordance with some applications of theinvention;

FIGS. 4A-C are schematic illustrations of a prosthetic valve, comprisinga tubular element and a valve member, in accordance with someapplications of the invention; and

FIGS. 5A-C are schematic illustrations of a prosthetic valve comprisinga tubular element and a valve member, in accordance with someapplications of the invention.

DETAILED DESCRIPTION OF EMBODIMENTS

Reference is made to FIGS. 1A-D, which are schematic illustrations of aprosthetic valve 20, comprising a tubular element 22 and a valve member24, in accordance with some applications of the invention. It is to benoted that throughout this application, including the specification andthe claims, the term “valve member” is defined as the movableobstruction (e.g., inside the tubular element) that restricts and/orcontrols flow through the valve, as is known in the general valve art.Prosthetic valve 20 is configured to be placed in a lumen of the body ofthe subject, such as in a blood vessel and/or at a native valve of thesubject. Typically, prosthetic valve 20 is configured to be placed at anative heart valve of a subject, and to replace native functionality ofthe native valve. FIG. 1A shows tubular element 22 alone, FIG. 1B showsvalve member 24 alone, FIG. 1C shows valve 20 in a compressedconfiguration thereof, and FIG. 1D shows valve 20 in an expandedconfiguration thereof, in accordance with some applications of theinvention.

FIG. 1A shows tubular element 22, in an expanded configuration thereof,in accordance with some applications of the invention. Tubular element22 is shaped to define a lumen 23 therethrough, and has a length d 1along a longitudinal axis of the tubular element, from a first end ofthe lumen to a second end of the lumen (e.g., from a first end ofelement 22 to a second end of element 22). Lumen 23 is defined by aninner surface 36 (FIG. 1D) of tubular element 22, and has a width d2.That is, d2 represents an inner width of tubular element 22. Typically,tubular element 22 is generally cylindrical (i.e., element 22 has agenerally circular transverse cross-section), and width d2 represents adiameter of lumen 23. Alternatively, tubular element 22 has a transversecross-section that is not generally circular, and width d2 represents amaximum width of lumen 23.

Typically, length d1 is greater than 10 mm and/or less than 30 mm (e.g.,10-30 mm). Typically, width d2 is greater than 20 mm and/or less than 40mm (e.g., 20-40 mm, such as 30 mm). That is, in the expandedconfiguration thereof (as shown in FIG. 1A), tubular element 22 haslength of greater than 10 mm and/or less than 30 mm, and an inner widthof greater than 20 mm and/or less than 40 mm.

Typically, tubular member 22 comprises a frame 26 that defines acircumferentially-repeating arrangement of cells 27. Typically, frame 26defines, along length d1, longitudinal columns c1 comprising one cell27, alternating with longitudinal columns c2 comprising two cells.Typically, frame 26 defines circumferential rows comprising more than 10and/or less than 25 cells 27 (e.g., 18 cells). It is to be noted,however, that the scope of the invention includes other configurationsof frame 26.

FIG. 1B shows valve member 24, in an expanded configuration thereof, inaccordance with some applications of the invention. Valve member 24typically has a shape that is similar to that of lumen 23 of tubularelement 22. That is, a transverse cross-section of valve member 24typically has a shape that is similar to the shape of the transversecross-section of lumen 23. For example, for applications in whichtubular element 22 is generally cylindrical, valve member 24 typicallyhas a generally disc-shaped transverse cross-section. For suchapplications, other dimensions and/or shapes of valve member 24 may vary(e.g., as described with reference to FIGS. 2A-B).

Typically, valve member 24 has a width d4 that is no more than 20percent smaller than width d2 of tubular element 22 (e.g., no more than10 percent smaller, such as no more than 5 percent smaller). Forapplications in which tubular element 22 is generally cylindrical andvalve member is generally disc-shaped, widths d3 and d4 representtransverse cross-sectional diameters of lumen 23 and valve member 24,respectively, and the diameter of valve member 24 is typically no lessthan 20 percent smaller than the diameter of lumen 23 (i.e., no lessthan 20 percent smaller than the inner diameter of tubular element 22).Thereby, width d4 is typically greater than 20 mm and/or less than 40 mm(e.g., 20-40 mm, such as 30 mm).

Typically, valve member 24 comprises a frame 28 that defines an outeredge 30, an inner edge 32, and a radially-repeating arrangement of cells29, disposed between the inner and outer edges. Inner edge 32 defines anopening 42, the presence of which facilitates compression of valvemember 24 into the compressed configuration thereof (e.g., as describedwith reference to FIG. 1C). That is, the absence of frame material atopening 42 facilitates compression of the valve member into a generallycylindrical shape. Typically, opening 42 has a width d5 (e.g., adiameter) of more than 5 mm and/or less than 20 mm (e.g., between 5 and20 mm, such as 12 mm). Alternatively or additionally, frame 28 maycomprise a portion of increased flexibility, e.g., instead of definingopening 42.

For clarity, FIGS. 1A-B show frames 26 and 28 of tubular element 22 andvalve member 24, respectively. However, tubular element 22 and valvemember 24 comprise a covering 40, e.g., as shown in FIGS. 1C-D. Covering40 covers at least part of frames 26 and 28. Non-limiting examples ofmaterials that covering 40 may comprise, include cotton and polymers(e.g., polyester). Typically the covering has a thickness that is lessthan 1 mm (e.g., between 0.05 mm and 0.6 mm).

FIG. 1C shows valve 20 in the compressed configuration thereof, in whichvalve member 24, in a compressed configuration thereof, is disposedwithin lumen 23 of tubular element 22, in the compressed configurationthereof. FIG. 1D shows valve 20 in the expanded configuration thereof,in which valve member 24, in an expanded configuration thereof, isdisposed within lumen 23 of tubular element 22, in an expandedconfiguration thereof.

Valve 20 is configured to be percutaneously (e.g., transcatheterallyand/or transluminally, such as transfemorally) delivered to the nativeheart valve of a subject, by being compressed (e.g., “crimped”) into thecompressed configuration thereof (i.e., a delivery configurationthereof). Valve 20 is typically configured to be restrained in thecompressed configuration (e.g., by an overtube) during delivery of thevalve, and to automatically move into an expanded configuration whenreleased (e.g., by being deployed from the overtube). Typically, frames26 and 28 comprise a shape-memory material such as, but not limited to,nitinol, which facilitates this automatic expansion.

Covering 40 typically covers inner surface 36 of cylindrical element 22and at least one side of valve member 24, including opening 42. Opening42 is thereby an opening in frame 28 but typically not an opening incovering 40, and thereby typically not an opening through the entire ofvalve member 24 (FIG. 1D).

As described hereinabove, tubular element 22 is typically generallycylindrical.

That is, element 22 is typically generally cylindrical in the expandedconfiguration thereof. Tubular element 22 is typically also generallycylindrical in the compressed configuration thereof. In the compressedconfiguration thereof, tubular element 22 (e.g., lumen 23 thereof) has awidth d6 (e.g., a diameter) that is smaller than width d2 of the tubularelement in the compressed configuration thereof. Typically, width d2 ismore than 1.5 times (e.g., more than 4 times) greater than width d6.

As described hereinabove, valve member 24 is typically generallydisc-shaped. That is, member 24 is typically generally disc-shaped inthe expanded configuration thereof. In the compressed configurationthereof, valve member 24 is typically elongate, such as generallycylindrical, and has a width (e.g., a diameter) d7. Typically, width d4(FIG. 1B) is more than twice (e.g., more than 5 times, such as more than10 times) greater than width d7. Typically, when valve member 24 movesfrom the compressed configuration to the expanded configuration, (1) afirst end 33 of the cylinder defined by valve member 24 in thecompressed configuration, expands to define outer edge 30 of the valvemember in the expanded configuration, and a second end 35 of thecylinder expands to define inner edge 32. It is to be noted thatcovering 40 covers opening 42 in frame 28, and therefore inner edge 32is an inner edge of frame 28, and does not define an opening through theentire of valve member 24.

Valve member 24 is typically disposed in lumen 23 of tubular element 22,in both the compressed configuration and the expanded configuration ofvalve 20. Valve member 24 is coupled to tubular element 22 at one ormore (e.g., two) coupling points 60. Coupling points 60 comprise acoupling element 61, which may comprise a hinge, a connector (e.g., aconnecting wire or suture), or any other suitable coupling element. Forsome applications, and as shown in FIG. 1D, coupling element 61comprises a hinge formed by a protrusion 59 of frame 28 protruding intoa slot 57 defined by frame 26. Typically, and as described in moredetail with reference to FIGS. 3A-B, valve 20 further comprises one ormore valve seats 62, configured to facilitate sealing between tubularelement 22 and valve member 24.

Typically, width d6 is greater than 2 mm and/or less than 12 mm (e.g.,2-10 mm, such as 3-6 mm). Typically, width d7 is greater than 2 mmand/or less than 10 mm (e.g., 2-8 mm, such as 2-6 mm). Typically, valvemember 24 is configured to be compressible such that width d7 is smallerthan width d6 in a maximally-compressed configuration of cylindricalelement 22, e.g., such that cylindrical element 22 is compressible togenerally the same width in the presence or absence of valve member 24.

As described hereinabove, prosthetic valve 20 is configured to be placed(i.e., implanted) at a native heart valve of a subject, and to replacenative functionality of the native valve. Prosthetic valve 20 isconfigured to act as a one-way valve (e.g., a check valve). That is,prosthetic valve 20 is configured to generally allow blood to flow in afirst direction through lumen 23 of tubular element 22, and to inhibitblood from flowing in a second direction through the lumen. Typically,prosthetic valve 20 resembles and/or is configured to act as a “tiltingdisc” valve, as is known in the valve art. Valve member 24, disposed inlumen 23 of tubular element 22, provides valve functionality by beingconfigured to move between an open state and a closed state in responseto changes in relative pressure between each end of the lumen of tubularelement 22 (i.e., in response to changes in relative pressure betweenblood at each end of the lumen; e.g., as described hereinbelow withreference to FIGS. 3A-B). Movement of valve member 24 between the openand closed states thereof, thereby moves prosthetic valve 20 betweenopen and closed states thereof.

Reference is made to FIGS. 2A-B, which arc schematic illustrations ofvalve member 24, in accordance with respective applications of theinvention. As described hereinabove, valve member 24 is typicallydisc-shaped in the expanded configuration thereof. FIG. 2A shows valvemember 24, comprising a disc-shaped valve member 24 a in the expandedconfiguration thereof, in accordance with some applications of theinvention. As described hereinabove, frame 28 and opening 42 of valvemember 24 are typically covered in covering 40.

For some applications, valve member 24 has a shape that is different toa flat disc. FIG. 2B shows valve member 24, comprising a frustoconicalvalve member 24 b in the expanded configuration thereof, in accordancewith some applications of the invention. For some applications of theinvention, frame 28 of valve member 24 b comprises a frame 28 b, whichis configured to assume a frustoconical shape. For some applications ofthe invention, covering 40 of valve member 24 b comprises a covering 40b, which is configured to facilitate the valve member assuming thefrustoconical shape, e.g., by restricting full expansion of the frame.For some such applications, valve member 24 b comprises frame 28 (i.e.,the same frame as member 24 a), and the assuming of the frustoconicalshape of valve member 24 b is facilitated mainly (e.g., solely) bycovering 40 b.

It is to be noted that FIGS. 2A-B show non-limiting examples of possibleshapes of valve member 24, and that the scope of the invention includesvalve member 24 having other shapes. Similarly, it is to be noted that,although tubular element 22 is shown as being substantially cylindrical,the scope of the invention includes tubular element 22 having othershapes, e.g., so as to facilitate blood flow, so as to conform to theshape of the native valve, and/or so as to facilitate coupling to thenative valve and/or to auxiliary apparatus, such as a prosthetic valvesupport, such as the prosthetic valve supports described in US2012/0022640 to Gross et al., which is incorporated herein by reference.For example, tubular element 22 may comprise and/or define flared ends,barbs, clips, or any other such features, e.g., as are known in the art.

Reference is made to FIGS. 3A-B, which are schematic illustrations offunctioning of valve 20, in accordance with respective applications ofthe invention. FIGS. 3A-B show valve member 24 as disc-shaped (e.g., asshown for valve member 24 a, described with reference to FIG. 2A), butvalve members of other shapes may be used, and typically functionsimilarly, mutatis mutandis.

Valve member 24 is coupled to tubular element 22 at one or more couplingpoints 60, such that the valve member can rotate between (1) an openstate in which the valve member generally allows fluid (e.g., blood) toflow through lumen 23, and (2) a closed state in which the valve membergenerally blocks lumen 23, thereby generally inhibiting fluid fromflowing through the lumen. Typically, valve member 24 is coupled totubular element 22 at two coupling points 60 (e.g., coupling points 60 aand 60 b), such that the valve member can rotate around an axis albetween the two coupling points. Typically, valve member 24 does notchange shape when moving between the open and closed states. FIG. 3Ashows valve member 24 (and thereby valve 20) in the closed statethereof, and FIG. 3B shows valve member 24 (and thereby valve 20) in theopen state thereof.

Typically, coupling points 60 a and 60 b do not lie on a centraltransverse axis a2 of tubular element 22. That is, axis al is typicallya non-diameter chord of a transverse cross-section of tubular element22. Such a configuration typically facilitates the functioning of valve20 as a tilting-disc valve, as is known in the art.

Valve 20 is configured such that valve member 24 moves between the openstate and the closed state in response to changes in relative fluidpressure between each end of lumen 23, and thereby valve 20 isconfigured to act as a one-way valve (e.g., a check valve). In the openstate, a first end 64 of tubular element 22 is in fluid communicationwith a second end 66 of the tubular element. In the closed state, fluidcommunication between the two ends is reduced, compared to in the openstate (e.g., the first and second ends are substantially not in fluidcommunication).

As shown in FIG. 3A, when fluid pressure at a second end 66 of tubularmember 22 is higher than fluid pressure at a first end 64 of the tubularmember (e.g., when fluid “tries” to move from the second end to thefirst end), valve member 24 is in (e.g., moves into) the closed state,thereby inhibiting flow of the fluid from the second end to the firstend. As shown in FIG. 3B, when fluid pressure at first end 64 is higherthan fluid pressure at second end 66 (e.g., when fluid “tries” to movefrom the first end to the second end), valve member 24 moves into theopen state, thereby facilitating flow of the fluid from the first end tothe second end. Thereby, valve 20 acts as a check-valve (e.g., atilting-disc valve), first end 64 is an upstream end of the valve, andsecond end 66 is a downstream end of the valve. It is to be noted that,when the valve member moves toward the open state, part of valve member24 moves toward first end 64 (i.e., upstream), and part of the valvemember moves toward second end 66 (i.e., downstream).

Valve member 24 is typically configured (e.g., dimensioned) such that,in the closed state, outer edge 30 (see FIG. 1B) of the valve member ispositioned closely to the inner surface of tubular element 22 (e.g., thevalve member is in close contact with the inner surface of the tubularelement). For example, and as described hereinabove, the diameter ofvalve member 24 is typically no more than 20 percent smaller than thewidth of the lumen of the tubular element.

For some applications of the invention, valve 20 further comprises atleast one valve seat 62, configured to facilitate contact (e.g.,sealing) between valve member 24 and tubular element 22. For some suchapplications, and as shown in FIGS. 3A-B, seat 62 comprises twoarc-shaped seats 62 a and 62 b that are disposed on the inner surface ofthe tubular element, and form respective arcs whose endpoints areadjacent to coupling points 60 a and 60b. For example, and as shown inFIGS. 3A-B, (1) seat 62 a forms a major arc between coupling points 60 aand 60 b, disposed slightly closer than coupling points 60 to first end64, and (2) seat 62 b forms a complementary minor arc, disposed slightlycloser than coupling points 60 to second end 66.

Seats 62 a and 62 b protrude into lumen 23 of tubular element 22, so asto facilitate sealing between the tubular element and valve member 24.For some applications, the seats comprise a sealing element, such as asealing surface, to further facilitate such sealing.

Typically, the seats and/or sealing elements comprise a fabric, a resinand/or a polymer and are configured to fold, crumple, contract, and/orcompress when valve 20 is compressed into the compressed configurationthereof, and to unfold, uncrumple, expand, and/or uncompress into theconfiguration shown in FIGS. 3A-B, when valve 20 is moved into theuncompressed configuration thereof. For example, the seats may comprisea fabric, sutured to frame 26, and configured to crumple and uncrumplewhen valve 20 is compressed and uncompressed, respectively.Alternatively or additionally, the seats may comprise an elasticmaterial, such as rubber silicone, that is configured to compress andstretch when valve 20 is compressed and uncompressed, respectively.

Reference is made to FIGS. 4A-C, which are schematic illustrations of aprosthetic valve 80, comprising a tubular element 82 and a valve member84, in accordance with some applications of the invention. FIG. 4A showsvalve 80 in a compressed configuration thereof, and FIGS. 4B-C showvalve 80 in an expanded configuration thereof, and functioning, inaccordance with some applications of the invention.

Typically, tubular element 82 comprises and/or has features of tubularelement 22, described hereinabove (e.g., with reference to FIGS. 1A-D).For example, tubular element 82 defines a lumen 83 therethrough,typically comprises a frame that defines a plurality of cells, and istypically expandable (e.g., automatically) from a generally cylindricalcompressed configuration (FIG. 4A) to a generally cylindrical expandedconfiguration (FIG. 4B).

Typically, valve member 84 comprises and/or has features of valve member24, described hereinabove (e.g., with reference to FIGS. 1A-D and/or2A-B). For example, valve member 84 is typically disc-shaped, typicallycomprises a frame that defines a plurality of cells, and is typicallyexpandable (e.g., automatically) from a generally cylindrical compressedconfiguration (FIG. 4A) to a generally disc-shaped expandedconfiguration (FIG. 4B).

Typically, the dimensions of valve 80 (e.g., the dimensions of tubularelement 82 and valve member 84) are similar (e.g., the same as) those ofvalve 20 (e.g., of tubular element 22 and valve member 24), describedhereinabove, mutatis mutandis.

As shown in FIG. 4A, in the compressed configuration of valve 80, valvemember 84, in the generally cylindrical compressed configurationthereof, is typically disposed within lumen 83 of tubular element 82, inthe generally cylindrical compressed configuration thereof. As shown inFIG. 4B, in the expanded configuration of valve 80, valve member 84, inthe generally disc-shaped expanded configuration thereof, is disposedwithin lumen 83 of tubular element 82, in the generally cylindricalexpanded configuration thereof.

Valve 80 comprises covering 40, which covers at least part of the framesof tubular element 82 and valve member 84 (e.g., as describedhereinabove for valve 20, mutatis mutandis). Typically, covering 40covers an inner surface 96 of tubular element 82, and at least one sideof valve member 84. Valve 80 is configured to be deliveredpercutaneously (e.g., transcatheterally and/or transluminally, such astransfemorally), e.g., as described hereinabove with respect to valve20, mutatis mutandis.

Valve member 84 is coupled to tubular element 82 at one or more (e.g.,two) coupling points 100, in both the compressed and expandedconfigurations of valve 80. Coupling points 100 comprise a couplingelement, which may comprise a hinge, a connector (e.g., a connectingwire or suture), or any other suitable coupling element. For someapplications, and as described for coupling element 61 hereinabove, eachcoupling element of valve 80 comprises a protrusion of the frame of thevalve member protruding into a slot defined by frame of the tubularelement.

Valve member 84 is coupled to tubular element 82 at the one or morecoupling points 100, such that the valve member can move between (1) anopen state in which the valve member generally allows fluid (e.g.,blood) to flow through lumen 83, and (2) a closed state in which thevalve member generally blocks lumen 83, thereby generally inhibitingfluid from flowing though the lumen. FIG. 4B shows valve member 84 (andthereby valve 80) in the closed state thereof, and FIG. 4C shows valvemember 84 (and thereby valve 80) in the open state thereof.

Typically, valve member 84 is coupled to tubular element 82 at twocoupling points 100 (e.g., coupling points 100 a and 100 b), such thatvalve member 84 can deflect (e.g., bend) around an axis a3 between thetwo coupling points. Typically, coupling points 100 a and 100 b lie on acentral transverse axis a4 (e.g., a diameter) of tubular element 82, andaxis a3 acts as a central fixed axis around which each resulting half ofvalve member 84 deflects. Further typically, and as shown in FIGS. 4A-C,the coupling element of valve 80 comprises a coupling rod 92, which iscoupled to valve member 84 along axis a3, and to coupling points 100 aand 100 b, such that the valve member can move between the open andclosed states by bending around the coupling rod. Coupling rod 92 isconfigured to be bent when valve 80 is compressed into the compressedconfiguration thereof (FIG. 4A), and to assume a generally straightconfiguration when the valve assumes the expanded configuration thereof(FIGS. 4A-B).

For some applications of the invention, valve member 84 comprises valvemember 24, described hereinabove. For some applications of theinvention, valve member 84 is unevenly rigid. For example, the valvemember may define an area of increased flexibility at and/or around axisa3 (e.g., at and/or around coupling rod 92), so as to facilitate themovement of valve member 84 between the open and closed states describedhereinabove. It is to be noted that, whereas valve member 24 ofprosthetic valve 20 typically moves between the open and closed statesthereof without changing shape, valve member 84 of prosthetic valve 80typically does change shape when moving between the open and closedstates thereof.

Valve 80 is configured such that valve member 84 moves between the openstate and the closed state in response to changes in relative fluidpressure between each end of lumen 83, and thereby valve 80 isconfigured to act as a one-way valve (e.g., a check valve). In the openstate, a first end 104 of tubular element 82 is in fluid communicationwith a second end 106 of the tubular element. In the closed state, fluidcommunication between the two ends is reduced, compared to in the openstate (e.g., the first and second ends are substantially not in fluidcommunication).

As shown in FIG. 4B, when fluid pressure at a second end 106 of tubularelement 82 is higher than fluid pressure at a first end 104 of thetubular member (e.g., when fluid “tries” to move from the second end tothe first end), valve member 84 is in (e.g., moves into) the closedstate, thereby inhibiting flow of the fluid from the second end to thefirst end. As shown in FIG. 4C, when fluid pressure at first end 104 ishigher than fluid pressure at second end 106 (e.g., when fluid “tries”to move from the first end to the second end), valve member 84 movesinto the open state, thereby facilitating flow of the fluid from thefirst end to the second end. Thereby, valve 80 acts as a check-valve,first end 104 is an upstream end of the valve, and second end 106 is adownstream end of the valve.

For some applications of the invention, movement of valve member 84between the open and closed states thereof is driven primarily by therelative pressure at each end of lumen 83. For some applications, valvemember 84 is biased (e.g., shape-set) toward assuming the closed state,e.g., in the absence of any substantial forces thereon.

Valve member 84 is typically configured (e.g., dimensioned) such that,in the closed state, an outer edge 90 of the valve member is disposedclose to inner surface 96 of tubular element 82 (e.g., the valve memberis in close contact with the inner surface of the tubular element). Forexample, the diameter of valve member 84 is typically no more than 20percent smaller than the width of the lumen of the tubular element.

For some applications of the invention, valve 80 further comprises avalve seat 102, configured to facilitate contact (e.g., sealing) betweenvalve member 84 and tubular element 82. For some such applications, andas shown in FIGS. 4B-C, seat 102 is annular, and is disposed on theinner surface of tubular element 82, slightly closer than couplingpoints 100 to first end 104 of the tubular element. Seat 102 protrudesinto lumen 83 of tubular element 82, so as to facilitate sealing betweenthe tubular element and valve member 84. For some applications, theseats comprise a sealing element, such as a sealing surface, to furtherfacilitate such sealing.

Typically, the seat and/or sealing element comprises a fabric, a resinand/or a polymer and is configured to fold, crumple, contract, and/orcompress when valve 80 is compressed into the compressed configurationthereof (FIG. 4A), and to unfold, uncrumple, expand, and/or uncompressinto the configuration shown in FIGS. 4B-C, when valve 80 is moved intothe uncompressed configuration. For example, the seat may comprise afabric, sutured to the frame of tubular element 82, and configured tocrumple and uncrumple when valve 80 is compressed and uncompressed,respectively. Alternatively or additionally, the seat may comprise anelastic material, such as rubber silicone, that is configured tocompress and stretch when valve 80 is compressed and uncompressed,respectively.

Reference is made to FIGS. 5A-C, which are schematic illustrations of aprosthetic valve 120, comprising a tubular element 122 and a valvemember 124, in accordance with some applications of the invention. FIG.5A shows valve 120 in a compressed configuration thereof, and FIGS. 5B-Cshow valve 120 in an expanded configuration thereof, and functioning, inaccordance with some applications of the invention.

Typically, tubular element 122 comprises and/or has features of tubularelement 22 and/or tubular element 82, described hereinabove (e.g., withreference to FIGS. 1A-D, and/or 4A-C). For example, tubular element 122defines a lumen 123 therethrough, typically comprises a frame thatdefines a plurality of cells, and is typically expandable (e.g.,automatically) from a generally cylindrical compressed configuration(FIG. 5A) to a generally cylindrical expanded configuration (FIG. 5B).

Typically, valve member 124 comprises and/or has features of valvemember 24 and/or valve member 84, described hereinabove (e.g., withreference to FIGS. 1A-D, 2A-B and/or 4A-C). For example, valve member124 is typically disc-shaped, typically comprises a frame that defines aplurality of cells, and is typically expandable (e.g., automatically)from a generally cylindrical compressed configuration (FIG. 5A) to agenerally disc-shaped expanded configuration (FIG. 5B).

Typically, the dimensions of valve 120 (e.g., the dimensions of tubularelement 122 and valve member 124) are similar (e.g., the same as) thoseof valve 20 (e.g., of tubular element 22 and valve member 24), describedhereinabove, mutatis mutandis.

As shown in FIG. 5A, in the compressed configuration of valve 120, valvemember 124, in the generally cylindrical compressed configurationthereof, is typically disposed within lumen 123 of tubular element 122,in the generally cylindrical compressed configuration thereof. As shownin FIG. 5B, in the expanded configuration of valve 120, valve member124, in the generally disc-shaped expanded configuration thereof, isdisposed within lumen 123 of tubular element 122, in the generallycylindrical expanded configuration thereof.

Valve 120 comprises covering 40, which covers at least part of theframes of tubular element 122 and valve member 124 (e.g., as describedhereinabove for valves 20 and 80, mutatis mutandis). Typically, covering40 covers an inner surface 136 of tubular element 82, and at least oneside of valve member 84. Valve 80 is configured to be deliveredpercutaneously (e.g., transcatheterally and/or transluminally, such astransfemorally), e.g., as described hereinabove with respect to valves20 and 80, mutatis mutandis.

Valve member 124 is coupled to tubular element 122 at at least onecoupling point 140, in both the compressed and expanded configurationsof valve 120. Valve 120 comprises a coupling element 141, which maycomprise a hinge, a connector (e.g., a connecting wire or suture), orany other suitable coupling element. Typically, and as shown in FIGS.5A-C, coupling element 141 comprises one or more struts 150 thatprotrude radially-inwardly from tubular element 122, and are coupled toa generally central point on valve member 124 (e.g., generally midwayacross the diameter of the valve member). Further typically, couplingelement 141 comprises another strut 152 that is coupled to struts 150,extends longitudinally from struts 150, and couples struts 150 to valvemember 124 by being coupled to the valve member.

Valve member 124 is coupled to tubular element 122 such that the valvemember can move between (1) an open state in which the valve membergenerally allows fluid (e.g., blood) to flow through lumen 123, and (2)a closed state in which the valve member generally blocks lumen 123,thereby generally inhibiting fluid from flowing though the lumen. FIG.5B shows valve member 124 (and thereby valve 120) in the closed statethereof, and FIG. 5C shows valve member 124 (and thereby valve 120) inthe open state thereof. Typically, valve member 124 is coupled totubular element 122 at coupling point 140 such that valve member 124 candeflect (e.g., bend, fold, and/or collapse) from the coupling point,such as by opening and closing in an umbrella-like or jellyfish-likefashion. Typically, coupling point 140 lies on a central longitudinalaxis a5 of tubular element 122 and at the center of valve member 124. Itis to be noted that, whereas valve member 24 of prosthetic valve 20typically moves between the open and closed states thereof withoutchanging shape, valve member 124 of prosthetic valve 120 typically doeschange shape when moving between the open and closed states thereof.

For some applications of the invention, valve member 124 comprises valvemember 24 and/or valve member 84, described hereinabove. For someapplications of the invention, valve member 124 is unevenly rigid. Forexample, the valve member may define one or more areas of increasedflexibility that extend radially from coupling point 140 so as tofacilitate the movement of valve member 124 between the open and closedstates described hereinabove.

Valve 120 is configured such that valve member 124 moves between theopen state and the closed state in response to changes in relative fluidpressure between each end of lumen 123, and thereby valve 120 isconfigured to act as a one-way valve (e.g., a check valve). In the openstate, a first end 144 of tubular element 122 is in fluid communicationwith a second end 146 of the tubular element. In the closed state, fluidcommunication between the two ends is reduced, compared to in the openstate (e.g., the first and second ends are substantially not in fluidcommunication).

As shown in FIG. 5B, when fluid pressure at a second end 146 of tubularelement 122 is higher than fluid pressure at a first end 144 of thetubular member (e.g., when fluid “tries” to move from the second end tothe first end), valve member 124 is in (e.g., moves into) the closedstate, thereby inhibiting flow of the fluid from the second end to thefirst end. As shown in FIG. 5C, when fluid pressure at first end 144 ishigher than fluid pressure at second end 146 (e.g., when fluid “tries”to move from the first end to the second end), valve member 124 movesinto the open state, thereby facilitating flow of the fluid from thefirst end to the second end. Thereby, valve 120 acts as a check-valve,first end 144 is an upstream end of the valve, and second end 146 is adownstream end of the valve.

For some applications of the invention, movement of valve member 124between the open and closed states thereof is driven primarily by therelative pressure at each end of lumen 123. For some applications, valvemember 124 is biased (e.g., shape-set) toward assuming the closed state,e.g., in the absence of any substantial forces thereon.

Valve member 124 is typically configured (e.g., dimensioned) such that,in the closed state, an outer edge 130 of the valve member is disposedclose to inner surface 136 of tubular element 122 (e.g., the valvemember is in close contact with the inner surface of the tubularelement). For example, the diameter of valve member 124 is typically nomore than 20 percent smaller than the width of the lumen of the tubularelement.

For some applications of the invention, valve 120 further comprises avalve seat 142, configured to facilitate contact (e.g., sealing) betweenvalve member 124 and tubular element 122. For some such applications,and as shown in FIGS. 5B-C, scat 142 is annular, and is disposed on theinner surface of tubular element 122. Seat 142 protrudes into lumen 123of tubular element 122, so as to facilitate sealing between the tubularelement and valve member 124. For some applications, the seats comprisea sealing element, such as a sealing surface, to further facilitate suchsealing.

Typically, the seat and/or sealing element comprises a fabric, a resinand/or a polymer and is configured to fold, crumple, contract, and/orcompress when valve 120 is compressed into the compressed configurationthereof (FIG. 5A), and to unfold, uncrumple, expand, and/or uncompressinto the configuration shown in FIGS. 5B-C, when valve 120 is moved intothe uncompressed configuration. For example, the seat may comprise afabric, sutured to the frame of tubular element 122, and configured tocrumple and uncrumple when valve 120 is compressed and uncompressed,respectively. Alternatively or additionally, the seat may comprise anelastic material, such as rubber silicone, that is configured tocompress and stretch when valve 120 is compressed and uncompressed,respectively.

Reference is again made to FIGS. 1A-5C. The prosthetic valves describedhereinabove are typically configured to be compressed (e.g., crimped) soas to have a greatest diameter of less than 12 mm (e.g., less than 9 mm,such as less than 6 mm). The prosthetic valves described hereinabove arethereby typically advantageously configured to be delivered via acatheter that is 34 Fr or narrower (e.g., 24 Fr or narrower, such as 18Fr or narrower), thereby facilitating percutaneous (e.g., transluminal,such as transfemoral) delivery.

Reference is again made to FIGS. 1A-5C. As described hereinabove, thevalve member of each prosthetic valve is typically disposed within thelumen of the tubular element of that prosthetic valve, in both thecompressed and uncompressed configurations of the prosthetic valve. Itis to be noted that, for some applications, in the compressedconfiguration of the prosthetic valve, the valve member is disposedoutside of the lumen of the tubular element. For example, in thecompressed configuration of the prosthetic valve, the tubular elementand the valve member may be generally collinear.

Reference is again made to FIGS. 1A-5C. As described hereinabove, thevalve member of each prosthetic valve is typically coupled to thetubular element of that prosthetic valve, in both the compressed anduncompressed configurations of the prosthetic valve (e.g., duringdelivery and after implantation). It is to be noted that, for someapplications, the valve member is intracorporeally couplable to thetubular element, such as after implantation of the tubular element. Forexample, the tubular element and valve member may be deliveredsequentially, whilst connected via one or more guiding filaments, theguiding filaments facilitating juxtaposition and coupling of tubularelement and valve member, such as by facilitating assembly of couplingelement (e.g., by guiding a protrusion or rod into a slot).

Typically, the prosthetic valves described herein arc implanted (and/orconfigured to be implanted) at a native valve of the subject such thatthe first end is upstream of the second end. For example, the valves maybe implanted at an atrioventricular valve of the subject (e.g., a mitralvalve of the subject) such that the first end is disposed in an atriumof the subject (e.g., a left atrium of the subject) and the second endis disposed in a ventricle of the subject (e.g., a left ventricle of thesubject). Thereby, the prosthetic valve replaces one-way valvefunctionality of the native valve, with one-way valve functionality ofthe prosthetic valve.

It will be appreciated by persons skilled in the art that the presentinvention is not limited to what has been particularly shown anddescribed hereinabove. Rather, the scope of the present inventionincludes both combinations and subcombinations of the various featuresdescribed hereinabove, as well as variations and modifications thereofthat are not in the prior art, which would occur to persons skilled inthe art upon reading the foregoing description.

1. Apparatus for use at a native valve of a heart of a subject, theapparatus comprising a prosthetic valve, the prosthetic valvecomprising: a first frame, defining an arrangement of cells; a secondframe; a first protrusion; and a second protrusion, wherein: theprosthetic valve has a compressed state in which the prosthetic valve istransluminally deliverable to the heart, and an expanded state intowhich the prosthetic valve is expandable within the heart, in theexpanded state, the first frame is generally cylindrical and has anexpanded width, and the prosthetic valve defines a lumen having a firstend and a second end, in the compressed state, the first frame and thesecond frame are both generally cylindrical, and the first frame has acompressed width that is smaller than the expanded width, in theexpanded state, the prosthetic valve provides directional fluid flowthrough the lumen by opening and closing in response to changes inrelative fluid pressure between the first end and the second end, theprosthetic valve defines a first coupling point, a second couplingpoint, and an axis therebetween, the axis lying on a transversecross-section of the first frame, and in both the compressed state andthe expanded state: at the first coupling point, the first protrusioncouples the second frame to the first frame by protruding into a firstslot defined by the first frame, and at the second coupling point, thesecond protrusion couples the second frame to the second frame byprotruding into a second slot defined by the second frame.
 2. Theapparatus according to claim 1, wherein, in the expanded state, theprosthetic valve provides directional fluid flow through the lumen bythe second frame rotating around the axis in response to changes inrelative fluid pressure between the first end and the second end.
 3. Theapparatus according to claim 1, wherein, in the expanded state, theprosthetic valve provides directional fluid flow through the lumen bythe second frame rotating deflecting around the axis in response tochanges in relative fluid pressure between the first end and the secondend.
 4. The apparatus according to claim 1, wherein the axis is anon-diameter chord of the transverse cross-section of the first frame.5. The apparatus according to claim 1, wherein the first frame defines aflared end that facilitates coupling of the prosthetic valve to thenative valve.
 6. The apparatus according to claim 1, wherein in both thecompressed state and the expanded state, the first frame circumscribesthe second frame.
 7. The apparatus according to claim 1, wherein, in theexpanded state, the prosthetic valve provides directional fluid flowthrough the lumen by opening and closing, without the second framechanging shape, in response to changes in relative fluid pressurebetween the first end and the second end.
 8. The apparatus according toclaim 1, wherein both the first frame and the second frame comprisenitinol.
 9. The apparatus according to claim 1, wherein, in the expandedstate, difference between (i) a transverse cross-sectional diameter ofthe first frame, and (ii) a transverse cross-sectional diameter of thesecond frame, is no more than 5 percent.
 10. The apparatus according toclaim 1, wherein the second frame has a compressed diameter in thecompressed configuration of the prosthetic valve, and an expandeddiameter in the in the expanded configuration of the prosthetic valve,and wherein the expanded diameter is at least twice as great as thecompressed diameter.
 11. The apparatus according to claim 1, wherein theprosthetic valve is configured such that, while the second frame remainscoupled to the first frame at the first coupling point and at the secondcoupling point, the second frame is movable with respect to the firstframe such that at least part of the second frame moves toward the firstend and at least part of the second frame moves toward the second end.12. The apparatus according to claim 1, wherein the prosthetic valve isconfigured: to be transluminally delivered in the compressedconfiguration by being restrained in the compressed configuration duringthe transluminal delivery, and to automatically expand toward theexpanded configuration thereof when no longer restrained.
 13. Theapparatus according to claim 1, further comprising a first covering thatat least partly covers the first frame, and a second covering that atleast partly covers the second frame.
 14. The apparatus according toclaim 13, wherein the first covering and the second covering arepolymeric coverings.